Decision Aid for Thyroid Nodules

Overseen By Jessica Alfano

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stony Brook University

Disqualifiers: Thyroid surgery, Thyroid cancer

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

134 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist people with small thyroid nodules that might be cancerous in making better treatment decisions. Participants will receive information about managing these nodules through the Thyroid Nodule Management Education program and will complete surveys to assess their satisfaction with the decision-making process. The trial targets individuals with nodules 2 cm or smaller who have not undergone previous thyroid surgery or had thyroid cancer. As an unphased trial, it offers participants valuable insights and education about their condition, empowering them to make informed decisions.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual medications, as the trial involves routine care and counseling.

What prior data suggests that this decision aid is safe for managing thyroid nodules?

Research has shown that thyroid nodules are common, and most are not cancerous. Understanding treatment options is important for managing these nodules. No evidence suggests that learning about managing thyroid nodules is unsafe.

This educational approach does not involve medication or medical procedures, making it generally easy to handle with no known side effects. It helps participants understand their condition and make informed decisions about their care. Those considering joining a trial for thyroid nodule management education should know it focuses on providing information to increase confidence in treatment choices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Thyroid Nodule Management Education" approach because it aims to empower patients with comprehensive knowledge about their condition. Unlike traditional options that primarily focus on medical interventions like surgery or fine-needle aspiration biopsies, this educational approach seeks to enhance decision-making by providing detailed information on thyroid nodules. By equipping patients with a better understanding, this method could lead to more personalized and informed treatment choices, potentially reducing unnecessary procedures and anxiety.

What evidence suggests that this decision aid is effective for managing thyroid nodules?

Research has shown that when patients with unclear thyroid nodules learn about their options, it influences their decisions. In one study with 956 patients, 56% chose surgery, while 43% opted to wait and watch. This finding demonstrates that clear information helps patients make choices they feel confident about. In this trial, participants will receive thyroid nodule information as part of the experimental treatment arm. Researchers are also testing artificial intelligence (AI) tools to simplify the identification of non-dangerous nodules. Overall, better information can lead to more informed and satisfying decisions about thyroid health. ^{4 5 6 7 8}

Who Is on the Research Team?

Lukasz Czerwonka, MD

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

This trial is for individuals with small thyroid nodules (2cm or smaller) that are possibly malignant or of uncertain nature, without a history of thyroid surgery or cancer. Participants will receive education on managing thyroid nodules and complete surveys to evaluate their satisfaction with the decision-making process.

Inclusion Criteria

My thyroid biopsy shows uncertain or cancerous results.

My thyroid nodule is 2cm or smaller.

Exclusion Criteria

I have had thyroid cancer in the past.

I have had surgery on my thyroid.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Consultation and Information

Participants receive information about management of thyroid nodules and complete brief surveys at the time of enrollment and shortly after the consultation appointment with the surgeon

1-2 weeks

2 visits (in-person)

Follow-up

Participants complete surveys a few months after the consultation or surgery to assess satisfaction with their decision and decision-making process

6 months

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Thyroid Nodule Management Education

Trial Overview The study focuses on providing patients with information about managing small potentially malignant or indeterminate thyroid nodules. It aims to see if this education affects patient satisfaction regarding treatment decisions after consulting with surgeons.

How Is the Trial Designed?

Group I: Thyroid nodule information Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Stony Brook University

Lead Sponsor

Trials

225

Recruited

41,700+

Published Research Related to This Trial

A statistical prediction model developed from a study of 261 thyroid nodules (204 benign and 57 malignant) identified key features like irregular shape and microcalcifications that are associated with cancer risk.

The model demonstrated high accuracy (92.5%) in predicting malignancy, suggesting it could serve as an effective decision support tool for managing thyroid nodules, particularly in distinguishing benign from malignant cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A predictive model to distinguish malignant and benign thyroid nodules based on age, gender and ultrasonographic features. Girardi, FM., Silva, LMD., Flores, CD.[2022]

There is a general consensus among major thyroid nodule guidelines from various organizations, but some disagreements exist, particularly regarding the use of scintigraphy and calcitonin screening, which may stem from differences in disease prevalence across countries.

Significant gaps in evidence highlight the need for further research, especially in defining ultrasound malignancy criteria and evaluating new diagnostic techniques, which currently require clinicians to rely on their judgment and patient preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thyroid nodule guidelines: agreement, disagreement and need for future research. Paschke, R., Hegedüs, L., Alexander, E., et al.[2022]

The increase in thyroid nodules detection is primarily due to more frequent use of diagnostic sonography, with most nodules being benign and rarely malignant.

Fine-needle aspiration cytology (FNAc) is crucial for determining whether a thyroid nodule is malignant, and management options for benign nodules include monitoring, iodine supplementation, hormone therapy, and newer techniques like laser photocoagulation, all requiring careful consideration of benefits and risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Benign thyroid nodules: diagnostic and therapeutic approach]. Durante, C., Cava, F., Paciaroni, A., et al.[2022]

Thyroid nodules are more common in older adults, but while they generally have a lower risk of being cancerous, any cancers that are found tend to be of a higher-risk type.

There is a lack of specific evidence for evaluating and managing thyroid nodules in older adults, making it crucial to consider individual patient circumstances and the potential risks and benefits of treatment, especially given their higher likelihood of serious health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thyroid Nodule Evaluation and Management in Older Adults: A Review of Practical Considerations for Clinical Endocrinologists. Ospina, NS., Papaleontiou, M.[2023]

The paper reviews existing resources for managing thyroid nodules, highlighting the strengths and weaknesses of narrative clinical guidelines and clinical risk calculators.

It introduces the Thyroid Nodule Management App (TNAPP), a web-based tool that transforms traditional guidelines into a computer-interpretable format, offering personalized recommendations for clinicians at the point of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-interpretable guidelines: electronic tools to enhance the utility of thyroid nodule clinical practice guidelines and risk stratification tools. Garber, JR., Patkar, V.[2023]

In a study of 956 patients with indeterminate thyroid nodules, 56% opted for surgery, while 43% chose surveillance, highlighting a significant preference for surgical intervention among patients.

Factors influencing the decision for surgery included larger nodule size, younger age, and higher Bethesda classification, but also varied significantly based on the attending surgeon and the payment model, suggesting a need for standardized management discussions to enhance patient-centered decision making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Choices in Managing Bethesda III and IV Thyroid Nodules: A Canadian Multi-institutional Study. Kuta, V., Forner, D., Azzi, J., et al.[2022]

The 2009 American Thyroid Association guidelines offer important recommendations for managing thyroid nodules and differentiated thyroid cancer based on the best available evidence.

Clinicians and patients should be cautious when applying these guidelines, as ongoing controversies and varying healthcare practices may influence the interpretation and implementation of the recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

2009 American Thyroid Association guidelines on thyroid nodules. Perros, P.[2019]

An optimized integration of AI decision aids in thyroid nodule management can reduce diagnostic time for senior radiologists without compromising accuracy, while junior radiologists may benefit more from a traditional all-AI strategy.

The study analyzed 1754 ultrasonographic images from 1048 patients to develop the optimized strategy and then tested it on 300 images from 268 patients, finding no significant differences in diagnostic sensitivity or specificity between the two approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integration of Artificial Intelligence Decision Aids to Reduce Workload and Enhance Efficiency in Thyroid Nodule Management. Tong, WJ., Wu, SH., Cheng, MQ., et al.[2023]

The revised American Thyroid Association guidelines provide updated recommendations for managing thyroid nodules and differentiated thyroid cancer, reflecting the latest research and therapeutic options.

These guidelines aim to enhance clinical strategies for optimal patient care, ensuring that healthcare providers have access to the most current data for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thyroid gland: Revised guidelines for the management of thyroid cancer. Boelaert, K.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05264857?term=THYROID%20CANCER&viewType=Table&rank=6

Decision Aid and Thyroid Nodules Management | ... Thyroid nodule size less or equal to 2cm. Exclusion Criteria: History of thyroid surgery; History of thyroid cancer. Ages Eligible for Study.

2. withpower.com withpower.com/trial/decision-aid-for-thyroid-nodules-1a6ef

Decision Aid for Thyroid Nodules In a study of 956 patients with indeterminate thyroid nodules, 56% opted for surgery, while 43% chose surveillance, highlighting a significant preference for ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2804991

Artificial Intelligence Decision Aids in Thyroid Nodule ... How can the integration of artificial intelligence (AI) decision aids be optimized to enhance efficiency in thyroid nodule management?

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40650885/

Integrating Artificial Intelligence in Thyroid Nodule ... This study evaluates the clinical and economic impact of KOIOS, an FDA-approved artificial intelligence (AI) tool for the management of TN.

5. medinform.jmir.org medinform.jmir.org/2025/1/e71740

Optimizing Thyroid Nodule Management With Artificial ... Objective: This study aimed to evaluate AI in real clinical settings for identifying potentially benign thyroid nodules initially deemed to be ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10600596/

Management of Thyroid Nodules - PMC - PubMed Central - NIH Thyroid nodules are common and the prevalence varies between 4 and 7% by palpation and 19–68% by high-resolution USG. Most thyroid nodules are benign, ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37191957/

Integration of Artificial Intelligence Decision Aids to Reduce ... This diagnostic study suggests that an optimized AI strategy in thyroid nodule management may reduce diagnostic time-based costs without sacrificing diagnostic ...

8. researchgate.net researchgate.net/publication/370816299_Integration_of_Artificial_Intelligence_Decision_Aids_to_Reduce_Workload_and_Enhance_Efficiency_in_Thyroid_Nodule_Management

Integration of Artificial Intelligence Decision Aids to Reduce ... Conclusions and relevance: This diagnostic study suggests that an optimized AI strategy in thyroid nodule management may reduce diagnostic time- ...